ACS Diagnostics Inc. is moving into exciting, unchartered territory in ambulatory cardiac monitoring with its Food and Drug Administration-cleared CORE 12, which stands for cardiac outpatient real-time ECG.
The mobile cardiac telemetry monitor is designed to analyze electrocardiography, or the electrical activity of the heart, in real time.
“CORE 12 tracks every heartbeat and transmits abnormal heartbeat up to our service center,” said Chief Executive Lorean Manera. The Irvine-based company, which has a Medicare-approved Independent Diagnostic Testing
Facility, is hiring for certified clinical cardiovascular technicians to monitor hearts 24/7.
ACS has been in ambulatory cardiac monitoring, since 1981.
Med Device, Cellphone
The device got FDA approval in 2011 but only launched early last year. “We needed to get [Federal Communications Commission] approval,” Manera said. He said the device, which includes an integrated cellphone for immediate transmission and communication with its diagnostic laboratory, uses built-in cellular modem technology to transmit information to and from the device in a patient information privacy-compliant fashion.
ACS took the less traveled path of developing both the software and hardware instead of leveraging existing smartphone devices. The latter requires two devices, a wireless monitor device and a smartphone that houses the digital platform, which presents a challenge to the elderly to have to wear and charge two devices, said Shannon Koerber, vice president of peripheral products.
The device, about the size of an iPhone, is designed to be multipurpose capable of performing mobile cardiac outpatient telemetry with irregular heart beat detection from 24 hours up to 30 days. It can also be used to perform a 12-lead EKG, which is an essential diagnostic tool in the management and treatment of any cardiac disease, or the reduction of blood supply to the heart.
The company is focused on growing CORE 12.
Its product is reimbursed and currently available only through physician prescription, but Manera said “there may be a time when the consumer marketplace is ready for a continuous ECG monitoring [device].”
Vertical Integration
ACS moved from Laguna Hills to a larger facility in Irvine two years ago to support growth related to CORE 12. The company expanded its diagnostic laboratory and is hiring engineers, sales reps and lab technicians.
Early detection of heart rhythm disorders, such as atrial fibrillation, can help avoid more serious downstream medical episodes like stroke and heart attack, and even death. The National Stroke Association estimates that up to 80% of stroke patients with atrial fibrillation are preventable with early detection and proper treatment.
“We continue to penetrate our existing customer base and are going after hospitals and [accountable care organizations],” said Ashton Gowadia, managing director of corporate finance. The formation of accountable care organizations—a network of doctors and hospitals that share financial and medical responsibility for providing coordinated care—is driven by recent healthcare reforms that reimburse care providers based on patient outcomes.
He said there is clinical advantage to using the device because it allows remote monitoring, as well as timely intervention. “Our lab contacts the patient if we don’t see activity,” he said.
Manera said there is tremendous opportunity to apply its phone technology to other areas, such as diabetes patient monitoring. He said the company is open to joint ventures and other partnerships.
